Reinnervated PAP Flap for Oral Cavity and Oropharyngeal Defect Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2027-05-31

Brief Summary

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The aim of this study is to investigate sensory recovery and functional outcomes following oral cavity and oropharyngeal defect reconstruction with reinnervated PAP (profunda artery perforator) flaps.

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Detailed Description

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Tumor resections involving the oral cavity or oropharynx cause significant functional deficits in swallowing and speech and subsequently impair the patients' quality of life. The anterolateral thigh (ALT) flap is widely regarded as a workhorse flap to reconstruct such defects. Previous studies assessing recovery of reinnervated ALT flaps reported superior sensory recovery, improved swallow function, and improved overall patient satisfaction in patients with reinnervated flaps compared with patients who received ALT flap reconstruction without sensory reinnervation. Recently, the profunda artery perforator (PAP) flap has been proposed as an alternative donor site in malnourished patients with thin lateral thigh thickness. However, reinnervation of PAP flaps has not been described. The study assesses sensory recovery after defect reconstruction with the reinnervated profunda artery perforator flap using already approved, non-invasive testing (Semmes-Weinstein monofilament testing, two-point discrimination, temperature, pain perception)

Conditions

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Oral Cavity Defect Oropharynx Defect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective case series (pilot study)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery

Oral cavity and oropharyngeal defect reconstruction

Group Type OTHER

Surgical reconstruction

Intervention Type PROCEDURE

Surgical reconstruction with a free reinnervated profunda artery perforator flap

Interventions

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Surgical reconstruction

Surgical reconstruction with a free reinnervated profunda artery perforator flap

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Patient with defect involving the oral cavity or oropharynx who undergo reconstruction with a free reinnervated profunda artery perforator flap

Exclusion Criteria

* \<18 years old
* Defect localizations other than the oral cavity or oropharynx
* Not able to give informed consent
* Inability to follow the procedures of the study, e.g., due to psychological disorders, dementia
* Inability or contraindications to undergo the investigated intervention

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No